scholarly journals Assessing the Food and Drug Administration’s Risk-Based Framework for Software Precertification With Top Health Apps in the United States: Quality Improvement Study (Preprint)

2020 ◽  
Author(s):  
Noy Alon ◽  
Ariel Dora Stern ◽  
John Torous
Keyword(s):  
United States ◽  
Quality Improvement ◽  
Health Information ◽  
Digital Health ◽  
The United States ◽  
Health Condition ◽  
User Engagement ◽  
Regulatory Review ◽  
Regulatory Guidance ◽  
Health Apps

BACKGROUND As the development of mobile health apps continues to accelerate, the need to implement a framework that can standardize the categorization of these apps to allow for efficient yet robust regulation is growing. However, regulators and researchers are faced with numerous challenges, as apps have a wide variety of features, constant updates, and fluid use cases for consumers. As past regulatory efforts have failed to match the rapid innovation of these apps, the US Food and Drug Administration (FDA) has proposed that the Software Precertification (Pre-Cert) Program and a new risk-based framework could be the solution. OBJECTIVE This study aims to determine whether the risk-based framework proposed by the FDA’s Pre-Cert Program could standardize categorization of top health apps in the United States. METHODS In this quality improvement study during summer 2019, the top 10 apps for 6 disease conditions (addiction, anxiety, depression, diabetes, high blood pressure, and schizophrenia) in Apple iTunes and Android Google Play Store in the United States were classified using the FDA’s risk-based framework. Data on the presence of well-defined app features, user engagement methods, popularity metrics, medical claims, and scientific backing were collected. RESULTS The FDA’s risk-based framework classifies an app’s risk by the disease condition it targets and what information that app provides. Of the 120 apps tested, 95 apps were categorized as targeting a nonserious health condition, whereas only 7 were categorized as targeting a serious condition and 18 were categorized as targeting a critical condition. As the majority of apps targeted a nonserious condition, their risk categorization was largely determined by the information they provided. The apps that were assessed as not requiring FDA review were more likely to be associated with the integration of external devices than those assessed as requiring FDA review (15/58, 26% vs 5/62, 8%; <i>P</i>=.03) and health information collection (24/58, 41% vs 9/62, 15%; <i>P</i>=.008). Apps exempt from the review were less likely to offer health information (25/58, 43% vs 45/62, 72%; <i>P</i>&lt;.001), to connect users with professional care (7/58, 12% vs 14/62, 23%; <i>P</i>=.04), and to include an intervention (8/58, 14% vs 35/62, 55%; <i>P</i>&lt;.001). CONCLUSIONS The FDA’s risk-based framework has the potential to improve the efficiency of the regulatory review process for health apps. However, we were unable to identify a standard measure that differentiated apps requiring regulatory review from those that would not. Apps exempt from the review also carried concerns regarding privacy and data security. Before the framework is used to assess the need for a formal review of digital health tools, further research and regulatory guidance are needed to ensure that the Pre-Cert Program operates in the greatest interest of public health. CLINICALTRIAL

scholarly journals Assessing the Food and Drug Administration’s Risk-Based Framework for Software Precertification With Top Health Apps in the United States: Quality Improvement Study

10.2196/20482 ◽  
2020 ◽  
Vol 8 (10) ◽  
pp. e20482
Author(s):  
Noy Alon ◽  
Ariel Dora Stern ◽  
John Torous
Keyword(s):  
United States ◽  
Quality Improvement ◽  
Health Information ◽  
Digital Health ◽  
The United States ◽  
Health Condition ◽  
User Engagement ◽  
Regulatory Review ◽  
Regulatory Guidance ◽  
Health Apps

Background As the development of mobile health apps continues to accelerate, the need to implement a framework that can standardize the categorization of these apps to allow for efficient yet robust regulation is growing. However, regulators and researchers are faced with numerous challenges, as apps have a wide variety of features, constant updates, and fluid use cases for consumers. As past regulatory efforts have failed to match the rapid innovation of these apps, the US Food and Drug Administration (FDA) has proposed that the Software Precertification (Pre-Cert) Program and a new risk-based framework could be the solution. Objective This study aims to determine whether the risk-based framework proposed by the FDA’s Pre-Cert Program could standardize categorization of top health apps in the United States. Methods In this quality improvement study during summer 2019, the top 10 apps for 6 disease conditions (addiction, anxiety, depression, diabetes, high blood pressure, and schizophrenia) in Apple iTunes and Android Google Play Store in the United States were classified using the FDA’s risk-based framework. Data on the presence of well-defined app features, user engagement methods, popularity metrics, medical claims, and scientific backing were collected. Results The FDA’s risk-based framework classifies an app’s risk by the disease condition it targets and what information that app provides. Of the 120 apps tested, 95 apps were categorized as targeting a nonserious health condition, whereas only 7 were categorized as targeting a serious condition and 18 were categorized as targeting a critical condition. As the majority of apps targeted a nonserious condition, their risk categorization was largely determined by the information they provided. The apps that were assessed as not requiring FDA review were more likely to be associated with the integration of external devices than those assessed as requiring FDA review (15/58, 26% vs 5/62, 8%; P=.03) and health information collection (24/58, 41% vs 9/62, 15%; P=.008). Apps exempt from the review were less likely to offer health information (25/58, 43% vs 45/62, 72%; P<.001), to connect users with professional care (7/58, 12% vs 14/62, 23%; P=.04), and to include an intervention (8/58, 14% vs 35/62, 55%; P<.001). Conclusions The FDA’s risk-based framework has the potential to improve the efficiency of the regulatory review process for health apps. However, we were unable to identify a standard measure that differentiated apps requiring regulatory review from those that would not. Apps exempt from the review also carried concerns regarding privacy and data security. Before the framework is used to assess the need for a formal review of digital health tools, further research and regulatory guidance are needed to ensure that the Pre-Cert Program operates in the greatest interest of public health.

A Viewpoint of Security for Digital Health Care in the United States

2014 ◽  
Vol 2 (1) ◽  
pp. 1-21 ◽  
Author(s):  
Steven A. Demurjian ◽  
Alberto De la Rosa Algarín ◽  
Jinbo Bi ◽  
Solomon Berhe ◽  
Thomas Agresta ◽  
...  
Keyword(s):  
United States ◽  
Health Care ◽  
Health Information ◽  
Information Exchange ◽  
Digital Health ◽  
The United States ◽  
Hard Copy ◽  
Health Providers ◽  
Patient Portals ◽  
Health Records

In health care, patient information of interest to health providers, researchers, public health researchers, insurers, patients, etc., is stored in different locations via electronic media and/or hard-copy formats. All potential users need electronic access to health information technology systems such as: electronic health records, personal health records, patient portals, and ancillary systems such as imaging, laboratory, pharmacy, etc. Controlling access to information from multiple systems requires granularity levels of privileges ranging from one patient to a cohort to an entire population. In this paper, we present a viewpoint of the state of secure digital health care in the United States, focusing on the resources that need to be protected as dictated by legal entities and regulations, the available approaches in the present state-of-the art, and, the potential needs for the future of security for digital health care. By utilizing a real world scenario, the authors explore the limitations of health information exchange in the United States, and present one possible architecture for secure digital health care that builds on existing technology alternatives.

A Viewpoint of Security for Digital Health Care in the United States

2017 ◽  
pp. 1326-1344
Author(s):  
Steven A. Demurjian ◽  
Alberto De la Rosa Algarín ◽  
Jinbo Bi ◽  
Solomon Berhe ◽  
Thomas Agresta ◽  
...  
Keyword(s):  
United States ◽  
Health Care ◽  
Health Information ◽  
Information Exchange ◽  
Digital Health ◽  
The United States ◽  
Health Providers ◽  
Patient Portals ◽  
Health Records ◽  
Multiple Systems

In health care, patient information of interest to health providers, researchers, public health researchers, insurers, patients, etc., is stored in different locations via electronic media and/or hard-copy formats. All potential users need electronic access to health information technology systems such as: electronic health records, personal health records, patient portals, and ancillary systems such as imaging, laboratory, pharmacy, etc. Controlling access to information from multiple systems requires granularity levels of privileges ranging from one patient to a cohort to an entire population. In this paper, we present a viewpoint of the state of secure digital health care in the United States, focusing on the resources that need to be protected as dictated by legal entities and regulations, the available approaches in the present state-of-the art, and, the potential needs for the future of security for digital health care. By utilizing a real world scenario, the authors explore the limitations of health information exchange in the United States, and present one possible architecture for secure digital health care that builds on existing technology alternatives.

A Viewpoint of Security for Digital Health Care in the United States

2016 ◽  
pp. 1245-1263
Author(s):  
Steven A. Demurjian ◽  
Alberto De la Rosa Algarín ◽  
Jinbo Bi ◽  
Solomon Berhe ◽  
Thomas Agresta ◽  
...  
Keyword(s):  
United States ◽  
Health Care ◽  
Health Information ◽  
Information Exchange ◽  
Digital Health ◽  
The United States ◽  
Health Providers ◽  
Patient Portals ◽  
Health Records ◽  
Multiple Systems

In health care, patient information of interest to health providers, researchers, public health researchers, insurers, patients, etc., is stored in different locations via electronic media and/or hard-copy formats. All potential users need electronic access to health information technology systems such as: electronic health records, personal health records, patient portals, and ancillary systems such as imaging, laboratory, pharmacy, etc. Controlling access to information from multiple systems requires granularity levels of privileges ranging from one patient to a cohort to an entire population. In this paper, we present a viewpoint of the state of secure digital health care in the United States, focusing on the resources that need to be protected as dictated by legal entities and regulations, the available approaches in the present state-of-the art, and, the potential needs for the future of security for digital health care. By utilizing a real world scenario, the authors explore the limitations of health information exchange in the United States, and present one possible architecture for secure digital health care that builds on existing technology alternatives.

Patients' Perceptions of Different Information Exchange Mechanisms: An Exploratory Study in the United States

2020 ◽  
Vol 59 (04/05) ◽  
pp. 162-178
Author(s):  
Pouyan Esmaeilzadeh
Keyword(s):  
United States ◽  
Health Care ◽  
Health Information ◽  
Health Care Providers ◽  
Information Exchange ◽  
The United States ◽  
Exchange Mechanism ◽  
Care Providers ◽  
Security Risks ◽  
Direct Exchange

Abstract Background Patients may seek health care services from various providers during treatment. These providers could serve in a network (affiliated) or practice separately (unaffiliated). Thus, using secure and reliable health information exchange (HIE) mechanisms would be critical to transfer sensitive personal health information (PHI) across distances. Studying patients' perceptions and opinions about exchange mechanisms could help health care providers build more complete HIEs' databases and develop robust privacy policies, consent processes, and patient education programs. Objectives Due to the exploratory nature of this study, we aim to shed more light on public perspectives (benefits, concerns, and risks) associated with the four data exchange practices in the health care sector. Methods In this study, we compared public perceptions and expectations regarding four common types of exchange mechanisms used in the United States (i.e., traditional, direct, query-based, patient-mediated exchange mechanisms). Traditional is an exchange through fax, paper mailing, or phone calls, direct is a provider-to-provider exchange, query-based is sharing patient data with a central repository, and patient-mediated is an exchange mechanism in which patients can access data and monitor sharing. Data were collected from 1,624 subjects using an online survey to examine the benefits, risks, and concerns associated with the four exchange mechanisms from patients' perspectives. Results Findings indicate that several concerns and risks such as privacy concerns, security risks, trust issues, and psychological risks are raised. Besides, multiple benefits such as access to complete information, communication improvement, timely and convenient information sharing, cost-saving, and medical error reduction are highlighted by respondents. Through consideration of all risks and benefits associated with the four exchange mechanisms, the direct HIE mechanism was selected by respondents as the most preferred mechanism of information exchange among providers. More than half of the respondents (56.18%) stated that overall they favored direct exchange over the other mechanisms. 42.70% of respondents expected to be more likely to share their PHI with health care providers who implemented and utilized a direct exchange mechanism. 43.26% of respondents believed that they would support health care providers to leverage a direct HIE mechanism for sharing their PHI with other providers. The results exhibit that individuals expect greater benefits and fewer adverse effects from direct HIE among health care providers. Overall, the general public sentiment is more in favor of direct data transfer. Our results highlight that greater public trust in exchange mechanisms is required, and information privacy and security risks must be addressed before the widespread implementation of such mechanisms. Conclusion This exploratory study's findings could be interesting for health care providers and HIE policymakers to analyze how consumers perceive the current exchange mechanisms, what concerns should be addressed, and how the exchange mechanisms could be modified to meet consumers' needs.

Achieving More Rapid Door-to-Needle Times and Improved Outcomes in Acute Ischemic Stroke in a Nationwide Quality Improvement Intervention

Stroke ◽  
2021 ◽  
Author(s):  
Ying Xian ◽  
Haolin Xu ◽  
Eric E. Smith ◽  
Jeffrey L. Saver ◽  
Mathew J. Reeves ◽  
...  
Keyword(s):  
United States ◽  
Quality Improvement ◽  
Ischemic Stroke ◽  
Thrombolytic Therapy ◽  
Phase I ◽  
Acute Ischemic Stroke ◽  
Symptom Onset ◽  
Odds Ratio ◽  
Adjusted Odds Ratio ◽  
The United States

Background and Purpose: The benefits of tPA (tissue-type plasminogen activator) in acute ischemic stroke are time-dependent. However, delivery of thrombolytic therapy rapidly after hospital arrival was initially occurring infrequently in hospitals in the United States, discrepant with national guidelines. Methods: We evaluated door-to-needle (DTN) times and clinical outcomes among patients with acute ischemic stroke receiving tPA before and after initiation of 2 successive nationwide quality improvement initiatives: Target: Stroke Phase I (2010–2013) and Target: Stroke Phase II (2014–2018) from 913 Get With The Guidelines-Stroke hospitals in the United States between April 2003 and September 2018. Results: Among 154 221 patients receiving tPA within 3 hours of stroke symptom onset (median age 72 years, 50.1% female), median DTN times decreased from 78 minutes (interquartile range, 60–98) preintervention, to 66 minutes (51–87) during Phase I, and 50 minutes (37–66) during Phase II ( P <0.001). Proportions of patients with DTN ≤60 minutes increased from 26.4% to 42.7% to 68.6% ( P <0.001). Proportions of patients with DTN ≤45 minutes increased from 10.1% to 17.7% to 41.4% ( P <0.001). By the end of the second intervention, 75.4% and 51.7% patients achieved 60-minute and 45-minute DTN goals. Compared with the preintervention period, hospitals during the second intervention period (2014–2018) achieved higher rates of tPA use (11.7% versus 5.6%; adjusted odds ratio, 2.43 [95% CI, 2.31–2.56]), lower in-hospital mortality (6.0% versus 10.0%; adjusted odds ratio, 0.69 [0.64–0.73]), fewer bleeding complication (3.4% versus 5.5%; adjusted odds ratio, 0.68 [0.62–0.74]), and higher rates of discharge to home (49.6% versus 35.7%; adjusted odds ratio, 1.43 [1.38–1.50]). Similar findings were found in sensitivity analyses of 185 501 patients receiving tPA within 4.5 hours of symptom onset. Conclusions: A nationwide quality improvement program for acute ischemic stroke was associated with substantial improvement in the timeliness of thrombolytic therapy start, increased thrombolytic treatment, and improved clinical outcomes.

scholarly journals Cash versus Lotteries: COVID-19 Vaccine Incentives Experiment

2021 ◽  
Author(s):  
Raymond M Duch ◽  
Adrian Barnett ◽  
Maciej Filipek ◽  
Laurence Roope ◽  
Mara Violato ◽  
...  
Keyword(s):  
United States ◽  
Health Information ◽  
Financial Incentives ◽  
Odds Ratio ◽  
Health Benefits ◽  
Credible Interval ◽  
The United States ◽  
Vaccine Uptake ◽  
Random Assignment

Governments are considering financial incentives to increase vaccine uptake to end the COVID-19 pandemic. Incentives being offered include cash-equivalents such as vouchers or being entered into lotteries. Our experiment involved random assignment of 1,628 unvaccinated participants in the United States to one of three 45 second informational videos promoting vaccination with messages about: (a) health benefits of COVID-19 vaccines (control); (b) being entered into lotteries; or (c) receiving cash equivalent vouchers. After seeing the control health information video, 16% of individuals wanted information on where to get vaccinated. This compared with 14% of those assigned to the lottery video (odds ratio of 0.82 relative to control: 95% credible interval 0.57-1.17) and 22% of those assigned to the cash voucher video (odds ratio of 1.53 relative to control: 95% credible interval 1.11-2.11). These results support greater use of cash vouchers to promote COVID-19 vaccine uptake and do not support the use of lottery incentives.

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